Treatment using intragastric balloons was introduced in the mid 1990s, being proposed as an attractive weight-loss option for patients who did not respond to medical therapy and who did not wish or should not undergo a surgical operation or drug treatment.
Said treatment comprises the use of a deflated inflatable balloon connected to the distal end of a tube for inflating or feeding the balloon which is inserted blind through the patient's mouth and passes through the oesophagus until it reaches the stomach. The balloon inflation tube must be long enough for the proximal end of said inflation tube to remain outside the patient. Once the deflated balloon is in the stomach, a syringe is inserted through the orifice at the proximal end of said inflation tube which projects from the patient's mouth and a liquid or air is introduced which inflates the balloon inside the stomach. Once the balloon is inflated in the stomach, the inflated balloon is released from the distal end of said inflation tube and said inflation tube is then removed from inside the body of the patient.
However, the process of placing the balloon, using known techniques, is carried out blind by touch and it is not possible to monitor where the balloon connected to the inflation tube is passing along. In some cases, said technique has led to incorrect insertion of the balloon causing injury to the oropharynx, larynx or trachea. To prevent incorrect insertion of the balloon via the trachea, in some cases the patient is intubated beforehand via the trachea to secure the airway and the balloon is then inserted connected to the inflation tube. However, the use of a respiratory probe requires more control than is necessary for inserting the balloon, causes the patient discomfort afterwards and does not ensure correct insertion of the balloon thus avoiding injuries.
An example of a device for inserting a gastric balloon is disclosed in patent application PCT WO 2012/089881. Said application discloses a device which is made up of a guide tube with a conical distal end connected adjacent to the inflation tube which in turn is connected to an inflatable balloon. The guide tube comprises an internal through-hole from the proximal end to the distal end for inserting a pre-guiding thread. Said thread is inserted in the patient's stomach beforehand and forms a pathway along which the guide tube is inserted together with the inflation tube and the inflatable balloon inside the stomach.
Although the device of application PCT WO 2012/089881 discloses an improvement for guiding the inflation tube connected to the balloon towards the stomach, there is still a risk that the inflation tube may become detached from the guide tube or even from the balloon due to rubbing on the oesophagus wall.
In addition, with this type of device comprising a pre-guiding thread which serves as a pathway for inserting the device and is inserted initially through the patient's oesophagus in a first step, the flexible nature of said thread means that often it forms kinks on the oesophagus wall. When this happens, and after the doctor has inserted the guide tube along said thread inside the patient, the conical distal end of said guide tube often becomes stuck at the point of said wall where said pre-guiding thread has formed a kink, as shown in FIG. 1, and can cause serious injuries to the oesophagus wall and may even lead to the perforation of said wall, most particularly in patients with diverticula in this route.
Moreover, both with this type of device and other devices of the prior art for inserting gastric balloons, the method used to release the inflated balloon inside the stomach usually takes place aided by the anatomical structure of the cardia (that is, the portion of the stomach next to the oesophagus). When the inflation tube is pulled out of the body of the patient, the cardia forms a stop for the inflated balloon, releasing the connection between the inflation tube and the inflated balloon, said inflated balloon being left free inside the stomach. However, in many cases this widespread practice causes serious damage and injuries to the cardia which, particularly in obese patients and above all in cases of morbid obesity, can cause internal bleeding that is difficult to stop or even, irreparable injuries especially in patients with a hiatus hernia.
An object of the present invention is therefore to produce a device for inserting a gastric balloon that allows said drawbacks to be overcome. More particularly, an object of the present invention is to disclose a device for inserting a gastric balloon which ensures correct insertion of the gastric balloon as far as the stomach, preventing said gastric balloon from being undesirably diverted towards other structures, and eliminating the risk of perforation and internal bleeding of the oropharynx, the airways or injuries to the stomach or the cardia. A further object of the present invention is to disclose a compact and efficient device that prevents the balloon from being released or detached or unhooked inopportunely and in addition does not use the assistance of the internal organs when the inflated balloon is to be released inside the stomach.